Symfony vs Vivity in Dim Light

Completed · Phase 4

Conditions studied: Cataract

In brief

The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.

Key facts

Study ID

NCT06229106

Run by

Carolina Eyecare Physicians, LLC

People needed

64

Starts

2023-12-01

Expected to finish

2024-10-30

Last updated by the study team

2025-02-14

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU.
• Gender: Males and Females.
• Age: 50 years and older.
• Willing and able to provide written informed consent for participation in the study
• Willing and able to comply with scheduled visits and other study procedures.
• Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries.
• Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if…

• Severe preoperative ocular pathology
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.
• Clinically significant corneal dystrophy.
• Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous intraocular surgery.
• Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
• Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)
• Previous keratoplasty
• Severe dry eye
• Pupil abnormalities
• Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK)
• Any clinically significant, serious, or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
• Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Where it is running

• Center for Sight — Sarasota, Florida, United States
• Carolina Eyecare Physicians, LLC — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.